[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22045-22049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0918]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection activity associated 
with statutory and regulatory food labeling requirements.

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 12, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-0918 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling Regulations.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

[[Page 22046]]


FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food Labeling Requirements

OMB Control Number 0910-0381--Revision

    This information collection supports statutory and regulatory 
requirements that govern food labeling, and information collection 
recommendations discussed in associated Agency guidance. Sections 4, 5, 
and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 
1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 
331, 342, 343, 348, 350, 371, and 379e), establish provisions under 
which a food product shall be deemed to be misbranded if, among other 
things, its label or labeling fails to bear certain required 
information concerning the food product, is false or misleading in any 
particular, or bears certain types of unauthorized claims. Implementing 
regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts 
101, 102, 104, and 105). While regulations in part 101 sets forth 
general food labeling provisions, requirements pertaining to the common 
or usual name for nonstandardized foods; guidelines for nutritional 
quality to prescribe the minimum level or range of nutrient composition 
appropriate for a given class of food; and requirements for foods for 
special dietary use are found in parts 102, 104, and 105, respectively. 
The requirements are intended to ensure the safety of food products 
produced or sold in the United States and enable consumers to be 
knowledgeable about the foods they purchase and include corresponding 
information disclosure requirements, along with the reporting and 
recordkeeping provisions, subject to enforcement by FDA.
    We provide information resources regarding Food Labeling under the 
FD&C Act and its amendments on our website at https://www.fda.gov/food/food-labeling-nutrition. Food labeling is required for most prepared 
foods, such as breads, cereals, canned and frozen foods, snacks, 
desserts, drinks, etc. Nutrition labeling for raw produce (fruits and 
vegetables) and fish is voluntary. We refer to these products as 
``conventional'' foods. For detailed information on dietary supplement 
labeling requirements visit our website at https://www.fda.gov/food/dietary-supplements. Nutrition labeling provides information for use by 
consumers in selecting a nutritious diet. Other information enables 
consumers to comparison shop. Ingredient information also enables 
consumers to avoid substances to which they may be sensitive. Petitions 
or other requests submitted to us provide the basis for us to permit 
new labeling statements or to grant exemptions from certain labeling 
requirements. Recordkeeping requirements ena ble us to monitor the 
basis upon which certain label statements are made for food products 
and whether those statements are in compliance with the requirements of 
the FD&C Act or the FPLA. Requirements include general content and 
format for the labeling of food packaging, including nutrition and 
ingredient information. Additional regulations provide for specific 
nutrient content claims.
    The information collection includes Form FDA 3570 entitled, ``Small 
Business Nutrition Labeling Exemption Notice,'' for use as applicable 
and available for download from our website at https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form. We have 
also developed the following guidance documents to assist respondents 
with various aspects of the information collection:
     ``Guidance for Industry: Notification of a Health Claim or 
Nutrient Content Claim Based on an Authoritative Statement of a 
Scientific Body'' (June 1998). The guidance document is available from 
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement. The guidance 
document discusses sections 403(r)(3) and 403(r)(2) (21 U.S.C. 
343(r)(3) and (2)) of the FD&C Act and was issued to provide 
instruction on the submission of information to FDA during the initial 
phase of implementing these new provisions.
     ``Questions and Answers: Labeling of Dietary Supplements 
as Required by the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act'' (September 2009). The guidance document is available 
from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary. The guidance 
document communicates content elements and FDA enforcement of labeling 
requirements in section 403(y) of the FD&C Act.
     ``Substantiation for Dietary Supplement Claims Made Under 
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act'' 
(January 2009). The guidance document is available from our website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food. The guidance document discusses 
FDA recommendations regarding claims under section 403(r)(6) of the 
FD&C Act.
    For operational efficiency, we are revising the information 
collection to account for burden that may result from activities 
associated with the labeling of certain beers, currently approved in 
OMB control number 0910-0728. The Tobacco Tax and Trade Bureau is

[[Page 22047]]

responsible for the dissemination and enforcement of regulations with 
respect to the labeling of distilled spirits, certain wines, and malt 
beverages issued in the Federal Alcohol Administration Act. However, 
and as discussed in the guidance document ``Labeling of Certain Beers 
Subject to the Labeling Jurisdiction of the Food and Drug 
Administration'' (December 2014), certain bottled or otherwise packaged 
beers are subject to section 403 of the FD&C Act. The guidance document 
is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration and provides recommendations regarding applicable 
labeling requirements for products under FDA's jurisdiction.
    We are also revising the information collection to include new 
requirements applicable to the gluten-free labeling of fermented or 
hydrolyzed foods established through rulemaking (RIN 0910-AH00) and 
approved in OMB control number 0910-0817.
    Description of Respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of food 
products, as well as certain food retailers, such as supermarkets and 
restaurants, subject to statutory and regulatory food labeling 
requirements.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
    21 CFR section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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101.9(c)(6)(i); dietary fiber...              28               1              28               1              28
101.9(j)(18) and 101.36(h)(2);            10,000               1          10,000               8          80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.....
101.12(h); petitions to                        1               1               1              80              80
 establish or amend referenced
 amounts customarily consumed
 (RACC).........................
101.69; petitions for nutrient                 3               1               3              25              75
 content claims.................
101.70; petitions for health                   5               1               5              80             400
 claims.........................
101.108; written proposal for                  1               1               1              40              40
 requesting temporary exemptions
 from certain regulations for
 the purpose of conducting food
 labeling experiments...........
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    Total.......................  ..............  ..............          10,038  ..............          80,623
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                   Number of
           21 CFR section; activity                Number of      records per    Total annual      Average  burden per  recordkeeping       Total hours
                                                 recordkeepers   recordkeeper       records
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101.9(c)(6)(iii); added sugars \2\............          31,283               1          31,283  1.......................................          31,283
101.9(c)(6)(i); dietary fiber \2\.............          31,283               1          31,283  1.......................................          31,283
101.9(c)(6)(i)(A); \2\ soluble fiber..........          31,283               1          31,283  1.......................................          31,283
101.9(c)(6)(i)(B); insoluble fiber \2\........          31,283               1          31,283  1.......................................          31,283
101.9(c)(8); vitamin E \3\....................          31,283               1          31,283  1.......................................          31,283
101.9(c)(8); folate/folic acid \3\............          31,283               1          31,283  1.......................................          31,283
New Products..................................             216               1             216  1.......................................             216
101.12(e); recordkeeping to document the basis              25               1              25  1.......................................              25
 for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the            300,000             1.5         450,000  0.75 (45 minutes).......................         337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document                300,000             1.5         450,000  0.75 (45 minutes).......................         337,500
 nutrition information related to health
 claims for food products.
101.22(i)(4); recordkeeping to document                     25               1              25  1.......................................              25
 supplier certifications for flavors
 designated as containing no artificial
 flavors.
101.100(d)(2); recordkeeping pertaining to               1,000               1           1,000  1.......................................           1,000
 agreements that form the basis for an
 exemption from the labeling requirements of
 section 403(c), (e), (g)-(i), (k), and (q) of
 the FD&C Act.
101.7(t); recordkeeping pertaining to                      100               1             100  1.......................................             100
 disclosure requirements for food not
 accurately labeled for quality of contents.
101.91; Documentation necessary to verify                5,000              56         280,000  0.45 (~27 minutes)......................         126,000
 compliance with gluten free labeling.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............       1,369,064  ........................................         990,064
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 22048]]

    Our estimate reflects the cumulative average burden we attribute to 
the reporting and recordkeeping requirements found in the applicable 
regulations; individual collection activities may not be evenly 
distributed among respondents and/or the corresponding requirements.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                   Number of
           21 CFR section; activity                Number of    disclosures per   Total annual       Average  burden per  disclosure        Total hours
                                                  respondents      respondent      disclosures
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101.3, 101.22, parts 102 and 104; statement of          25,000             1.03          25,750  0.5 (30 minutes).......................          12,875
 identity labeling requirements.
101.4, 101.22, 101.100, parts 102, 104 and              25,000             1.03          25,750  1......................................          25,750
 105; ingredient labeling requirements.
101.5; requirement to specify the name and              25,000             1.03          25,750  0.25 (15 minutes)......................           6,438
 place of business of the manufacturer,
 packer, or distributor and, if the food
 producer is not the manufacturer of the food
 product, its connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and             25,000             1.03          25,750  4......................................         103,000
 part 104; labeling requirements for
 disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative                   12                1              12  4......................................              48
 means of compliance permitted.
101.10; requirements for nutrition labeling of         300,000              1.5         450,000  0.25 (15 minutes)......................         112,500
 restaurant foods.
101.12(b); RACC for baking powder, baking                   29              2.3              67  1......................................              67
 soda, and pectin.
101.12(e); adjustment to the RACC of an                     25                1              25  1......................................              25
 aerated food permitted.
101.12(g); requirement to disclose the serving           5,000                1           5,000  1......................................           5,000
 size that is the basis for a claim made for
 the product if the serving size on which the
 claim is based differs from the RACC.
101.13(d)(1) and 101.67; requirements to                   200                1             200  1......................................             200
 disclose nutrition information for any food
 product for which a nutrient content claim is
 made.
101.13(j)(2) and (k), 101.54, 101.56, 101.60,            5,000                1           5,000  1......................................           5,000
 101.61, and 101.62; additional disclosure
 required if the nutrient content claim
 compares the level of a nutrient in one food
 with the level of the same nutrient in
 another food.
101.13(q)(5); requirement that restaurants             300,000              1.5         450,000  0.75 (45 minutes)......................         337,500
 disclose the basis for nutrient content
 claims made for their food.
101.14(d)(2); general requirements for                 300,000              1.5         450,000  0.75 (45 minutes)......................         337,500
 disclosure of nutrition information related
 to health claims for food products.
101.15; requirements pertaining to prominence              160               10           1,600  8......................................          12,800
 of required statements and use of foreign
 language.
101.22(i)(4); supplier certifications for                   25                1              25  1......................................              25
 flavors designated as containing no
 artificial flavors.
101.30 and 102.33; labeling requirements for             1,500                5           7,500  1......................................           7,500
 fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary                      300               40          12,000  4.025..................................          48,300
 supplements.
101.42 and 101.45; nutrition labeling of raw             1,000                1           1,000  0.5 (30 minutes).......................             500
 fruits, vegetables, and fish.
101.45(c); databases of nutrient values for                  5                4              20  4......................................              80
 raw fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements              1,000                1           1,000  0.25 (15 minutes)......................             250
 for food labels that contain a folate/neural
 tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of                  100                1             100  0.25 (15 minutes)......................              25
 folate for food labels that contain a folate/
 neural tube defect health claim.
101.100(d); disclosure of agreements that form           1,000                1           1,000  1......................................           1,000
 the basis for exemption from the labeling
 requirements of section 403(c), (e), (g),
 (h), (i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements           25,000             1.03          25,750  0.5 (30 minutes).......................          12,875
 for food not accurately labeled for quantity
 of contents and for claiming certain labeling
 exemptions.
Nutritional labeling for new products.........             500                1             500  2......................................           1,000
``Labeling of Certain Beers Subject to the                  12                1              12  1......................................              12
 Labeling Jurisdiction of the Food and Drug
 Administration''.
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[[Page 22049]]

 
    Total.....................................  ..............  ...............  ..............  .......................................       1,030,270
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates reflect our continued experience with the 
information collection. We have made nominal adjustments to reflect the 
addition of burden associated with gluten and certain bottled or 
otherwise packaged beer; petition submissions received since our last 
evaluation of the information collection; and informal communications 
with industry regarding food product labeling.

    Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07683 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P